About this service
Service process
Login to the MoHAP website or smart app using the UAE PASS.
Submit the request online and complete the payment to meet all conditions.
The competent technical committees will deliberate the registration of products and recommendations shall be submitted to the competent ministerial committee.
Letters are to be addressed to the concerned companies stating the committee's decisions.
The customer will follow up with the Analysis Section of at the Drug Department.
The company should complete the requirements and submit them online.
The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements.
The certificates of registration of products that have been approved for registration will be issued, provided all the conditions and requirements are met. Registration certificates are valid for five years effective the date of last expiry date of the previous certificate.
The pharmaceutical certificates (for locally manufactured pharmaceutical products) will be issued and be valid for one year effective the date of issuance.
Required documents
The application form of renewing the registration of medical equipment and reagents
The original registration certificate of the product issued previously by the Drug Control Department
A valid manufacturing certificate of the factory issued by MOHAP
Certificate of free sale/ registration issued by the competent authorities in the country of origin
A copy of all minor changes certificates issued by the Drug Control Department and certificates of quality conformity/ marketing authorization, such as EC, 510 (K), PMA as per the classification of the equipment, i.e. Class I, II, III, IV
Post-marketing monitoring requirements
Providing 3 samples (as per equipment type), certificate of analysis (as per equipment type), external and internal covers and brochures
Acknowledgment of the company that equipment conforms to the specifications as per the Medical Equipment Manual (EC-Declaration of Conformity)
Conditions and requirements
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products
The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license
Service completion duration
15 working days
Service fees
Application: 100 AED
Renewal of the registration of a medical device: 2,500 AED
Service channels
- MOHAP website: www.mohap.gov.ae
- MOHAP smart app
SDGs Goals
Service locations
- MOHAP Website - www.mohap.gov.ae -
- MOHAP Smart App
Payment channels
- E-payment
Target audience
Medical warehouses
Local pharmaceutical manufacturers
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-013-013
Service classification
- Government to business
Service type
Transactional
Sub service type
Auxiliary
Number of transactions
0
Notes
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
15 working days
Service fees
Application: 100 AED
Renewal of the registration of a medical device: 2,500 AED
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